Medical Devices Ordinance (MedDO) (MedDO)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Section 1 Requirements
Art. 6 General safety and performance requirements
1 A device may be placed on the market or put into service only if it complies with this Ordinance when duly supplied and properly installed, maintained and used in accordance with its intended purpose. 2 Devices shall meet the general safety and performance requirements set out in Annex I to EU-MDR, taking account of their intended purpose. 3 Appropriate evidence that the part of the combination that is deemed to be a device under the cases set out in Article 2 letters f–h and j fulfils the device requirements must be presented to the competent authority on demand. 4 If the device complies with the applicable technical standards designated by the Swiss Agency for Therapeutic Products (Swissmedic) or with common specifications, or relevant sections thereof, or with pharmacopoeial requirements in accordance with the Pharmacopoeia Ordinance of 17 October 2001, it is presumed that the device conforms with those requirements of this Ordinance covered by the applicable designated standards
Para. 2 — See the footnote to Art. 4 para. 1 let. f. Para. 3 — Amended by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291). Para. 4 — SR 812.211 Para. 4 — Amended by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291). Para. 5 — Amended by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291). Para. 6 —
Art. 7 Distance sales
1 Devices offered in Switzerland by means of an information society service – specifically an online service – that fulfil the conditions set out in paragraph 4 must comply with this Ordinance. 1bis Devices offered to users in Switzerland online or via some other form of distance sales are considered to be made available on the market. 2 Similarly, devices that are not placed on the market but are used in the context of a commercial activity, whether in return for payment or free of charge, for the provision of a diagnostic or therapeutic service offered by means of information society services or by other means of communication must also comply with this Ordinance. 3 Upon request by Swissmedic, any natural or legal person offering a device in accordance with paragraph 1 or providing diagnostic or therapeutic services in accordance with paragraph 2 must provide a copy of the declaration of conformity. 4 A device is deemed to be supplied via an information society service if that servic
Para. 1 — Amended by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291). Para. 1bis — Inserted by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291). Para. 3 — Amended by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291). Para. 5 — Repealed by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnosti
Art. 8 Specific requirements
1 Products without an intended medical purpose in accordance with Article 1 paragraph 1 letter b must comply with the common specifications stipulated by Swissmedic. 2 Devices that have both a medical and non-medical intended purpose must fulfil both the requirements for devices with an intended medical purpose and the requirements for products without an intended medical purpose. 3 Devices that are also machines within the meaning of Article 1 of the Machine Ordinance of 2 April 2008 must satisfy the pertinent general safety and health protection requirements of the Machine Ordinance where these requirements are more specific than those of Chapter II of Annex I to EU-MDR.
Para. 3 — SR 819.14 Para. 3 — See the footnote to Art. 4 para. 1 let. f.
Art. 9 Devices manufactured and used in healthcare institutions
1 Devices manufactured and used solely within healthcare institutions are deemed to have been put into service. Such devices are subject to the pertinent general safety and performance requirements of Annex I to EU-MDR but not to any of the other requirements set out in this Ordinance, provided the requirements of Article 5 paragraph 5 letters a–h EU-MDR are fulfilled. 2 Paragraph 1 does not apply to devices manufactured on an industrial scale.
Para. 1 — See the footnote to Art. 4 para. 1 let. f.
Art. 10 Custom-made devices
1 Custom-made devices are subject to the requirements of Annex XIII to EU-MDR. The devices must be accompanied by the statement referred to in Section 1 of Annex XIII to EU-MDR when they are placed on the market. 2 In addition to the procedure under paragraph 1, manufacturers of class III implantable custom-made devices must also carry out a conformity assessment procedure as specified in Chapter I of Annex IX to EU-MDR. Alternatively, they may opt for a conformity assessment in accordance with Part A of Annex XI to EU-MDR. 3 Manufacturers must draw up, keep up to date and keep available for competent authorities the documentation in accordance with Section 2 of Annex XIII to EU-MDR.
Para. 1 — See the footnote to Art. 4 para. 1 let. f.
Art. 11 Systems and procedure packs
1 The requirements of Articles 22 and 29 paragraph 2 EU-MDR apply to the placing on the market of systems and procedure packs. 2 Any natural or legal person who sterilises systems or procedure packs for placing on the market must apply a conformity assessment procedure for the sterilisation process and involve in that procedure a conformity assessment body that is designated under this Ordinance or recognised under an international agreement (designated body). The modalities for doing so are governed by Article 22 paragraph 3 EU-MDR. 3 Any natural or legal person who places the following systems or procedure packs on the market must fulfil the obligations of a manufacturer under Articles 46–50 and conduct the pertinent conformity assessment procedure under Article 23: Systems or procedure packs that: a. contain devices that do not carry a conformity marking; b. consist of a combination of devices that is not compatible with their original intended purpose; or c. have not been sterilise
Para. 1 — See the footnote to Art. 4 para. 1 let. f.
Art. 12 Parts and components
1 Any natural or legal person who makes available on the market an item intended to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or restore the function of the device without changing its performance or safety characteristics or its intended purpose shall ensure that the item does not adversely affect the safety and performance of the device. Supporting evidence must be kept available for the competent authority. 2 An item that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics or the intended purpose of the device shall be considered to be a device and shall meet the requirements laid down in this Ordinance.
Art. 13 Conformity marking and identification number
1 Devices placed on the market in Switzerland or made available on the Swiss market must bear a conformity marking in accordance with Annex 5. The conformity marking presented in Annex V to EU-MDR is also a permissible conformity marking. 2 The following must not bear a conformity marking: a. custom-made devices; b. devices exclusively for demonstration and presentation purposes; c. systems and procedure packs; d. investigational devices, subject to the provisions of Article 6 of the Ordinance of 1 July 2020 on Clinical Trials with Medical Devices (ClinO-MD); e. devices in accordance with Article 9. 3 Where devices’ conformity has to be assessed by a designated body, the identification number of this body must be affixed to the conformity marking.
Para. 1 — See the footnote to Art. 4 para. 1 let. f. Para. 2 let. d — Amended by No I of the O of 29 Sept. 2023, in force since 1 Nov. 2023 (AS 2023 576). Para. 2 let. d — SR 812.213.3 Para. 2 let. e — Amended by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291).
Art. 14 Affixing conformity markings and identification numbers
1 The conformity marking and, where necessary, the associated identification number shall be affixed to the device itself or its sterile packaging. 2 Where this is not possible or practicable owing to the nature of the device, the conformity marking and, where necessary, the associated identification number must be displayed on the packaging. 3 The conformity marking shall also appear in the instructions for use and on the sales packaging. 4 The requirements of Article 20 paragraphs 3–6 EU-MDR and the general principles of Article 30 Regulation (EC) No. 765/2008 must also be observed when affixing the conformity marking.
Para. 4 — See the footnote to Art. 4 para. 1 let. f. Para. 4 — Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93, last amended by OJ L 218 of 13.8.2008, p. 30.
Section 2 Classification, Product Information and
Amended by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291).
Art. 15 Classification
Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. This classification must comply with the provisions of Annex VIII to EU-MDR, taking account of the implementing acts of the European Commission listed in Annex 5a.
Art. 15 — Amended by No I of the O of 29 Sept. 2023, in force since 1 Nov. 2023 (AS 2023 576). See the footnote to Art. 4 para. 1 let. f.
Art. 16 Product information
1 Product information comprises the labelling and instructions for use. It is governed by Chapter III of Annex I to EU-MDR. 2 It must be written in all three official languages of Switzerland. Symbols established by means of technical standards may be used to replace written statements. 3 The product information may be provided in fewer than the three official languages of Switzerland or in English, provided that: a. the device is supplied exclusively to healthcare professionals or is a custom-made device or concerns a medical device in accordance with Article 9; b. the user meets the necessary professional and linguistic requirements and qualifications, and is in agreement; c. the protection of patients, users and third parties is ensured; and d. the efficacy and performance of the medical device are not placed at risk. 4 If requested, additional information must be provided to users in one of the official languages of Switzerland. 5 If a product cannot be, or cannot yet be, placed on
Para. 1 — See the footnote to Art. 4 para. 1 let. f. Para. 3 let. a — Amended by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291). Para. 3 let. b — Amended by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291).
Art. 17 Unique device identification
1 Any manufacturer or any natural or legal person who assembles systems and procedure packs in accordance with Article 22 paragraphs 1 and 3 EU-MDR shall assign to the device, system or procedure pack, with the exception of custom-made devices, and all higher levels of packaging a unique device identifier (UDI) prior to placing it on the market. 2 It must state the UDI on the labelling of the device, system or procedure pack and all higher levels of packaging. Shipping containers are not considered as a higher level of packaging. 3 It shall maintain a list of all the UDIs it has assigned. This list is part of the technical documentation specified in Annex II to EU-MDR. It must be kept up-to-date at all times. 4 The obligations and modalities associated with device identification and registration are governed by Articles 27 and 29 and Annex VI to EU-MDR, taking account of the amendments to this Annex adopted by the European Commission by means of delegated acts. 5 ...
Para. 1 — See the footnote to Art. 4 para. 1 let. f. Para. 1 — Stands for «Unique Device Identification» Para. 1 — Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281). Para. 2 — Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281). Para. 3 — Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281). Para. 4 — See Annex 4. Para. 5 — Enters into force at a later date (Art. 110 para. 2).
Section 3 Reporting Obligations and Information
Art. 18 Notification of devices manufactured in healthcare institutions
1 Healthcare institutions that manufacture and use devices as specified in Article 9 shall provide the following information to Swissmedic prior to putting the devices into service: a. their name and address; b. the name and intended purpose of the device; c. the risk class of the device in accordance with Article 15 paragraph 1. 2 Any other relevant information about these devices must be submitted to Swissmedic upon request. 3 Changes to the information required in paragraph 1 must be reported to Swissmedic within 30 days. 4 Depending on the risk inherent to a device and its use, Swissmedic may exempt devices manufactured and used in accordance with Article 9 from the reporting obligation.
Art. 18 — Amended by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291). Para. 2 — Amended by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291).
Art. 19 Reporting obligation for natural and legal persons who make custom-made devices available on the market
1 Any natural or legal person who makes custom-made devices available on the Swiss market must provide the following information to Swissmedic before making the devices available: a. the name and address of the manufacturer and all manufacturing sites; b. the name and address of the authorised representative if applicable; c. the codes required to identify the relevant product categories, as specified by the European Commission by means of implementing acts. 2 Changes to this information must be reported to Swissmedic within 30 days of the changes taking effect. 3 Depending on the risk inherent to a device and its use, Swissmedic may exempt custom-made devices from the reporting obligation under paragraph 1.
Para. 1 let. c — See Annex 4.
Art. 20 Information on implantable devices
1 For implantable products, the manufacturer must provide, in addition to the product information required under Article 16, the information required under Article 18 paragraph 1 EU-MDR, including the implant card. The exemptions specified under Article 18 paragraph 3 EU-MDR apply, taking account of the amendments adopted by the European Commission by means of delegated acts. 2 The implant card must drawn up in all three official languages of Switzerland. 3 Healthcare institutions must enter the details of the implant recipient in the implant card and give the card to the recipient. They provide the essential information needed by the recipient in a quickly accessible mean.
Para. 1 — See the footnote to Art. 4 para. 1 let. f. Para. 1 — See Annex 4.
